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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mattress, air flotation, alternating pressure
Regulation Description Alternating pressure air flotation mattress.
Product CodeFNM
Regulation Number 880.5550
Device Class 2

MDR Year MDR Reports MDR Events
2020 58 58
2021 47 47
2022 75 75
2023 197 197
2024 254 254
2025 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 87 87
Insufficient Information 80 80
Deflation Problem 59 59
Increase in Pressure 36 36
Sparking 32 32
Dent in Material 23 23
Use of Device Problem 20 20
Appropriate Term/Code Not Available 19 19
Inflation Problem 15 15
Unintended Deflation 13 13
Electrical Shorting 11 11
No Apparent Adverse Event 11 11
Patient-Device Incompatibility 11 11
Electrical /Electronic Property Problem 10 10
Unintended Electrical Shock 9 9
Melted 8 8
Infusion or Flow Problem 8 8
Smoking 7 7
Pressure Problem 6 6
Detachment of Device or Device Component 6 6
Fire 6 6
Malposition of Device 4 4
Patient Device Interaction Problem 4 4
Mechanical Problem 4 4
Difficult or Delayed Positioning 4 4
Device Slipped 4 4
Product Quality Problem 3 3
Gas/Air Leak 3 3
Defective Component 3 3
Protective Measures Problem 3 3
Disconnection 2 2
Device-Device Incompatibility 2 2
Therapeutic or Diagnostic Output Failure 2 2
Material Too Rigid or Stiff 2 2
Thermal Decomposition of Device 2 2
No Pressure 2 2
Material Split, Cut or Torn 2 2
Installation-Related Problem 2 2
Contamination /Decontamination Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Circuit Failure 2 2
Decrease in Pressure 2 2
Complete Loss of Power 2 2
Sharp Edges 2 2
Self-Activation or Keying 2 2
Inadequate or Insufficient Training 1 1
Decreased Pump Speed 1 1
Power Problem 1 1
Loose or Intermittent Connection 1 1
Failure to Power Up 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 228 228
Fall 154 154
Pressure Sores 100 100
Insufficient Information 34 34
Tissue Breakdown 33 33
Ulcer 16 16
Skin Tears 15 15
Pain 14 14
No Consequences Or Impact To Patient 11 11
Electric Shock 11 11
Bruise/Contusion 8 8
Head Injury 7 7
Bone Fracture(s) 7 7
Laceration(s) 6 6
Physical Entrapment 5 5
Localized Skin Lesion 5 5
Skin Erosion 4 4
Pleural Effusion 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Abrasion 4 4
Joint Dislocation 4 4
Burn(s) 3 3
Hematoma 3 3
Blister 3 3
Vertebral Fracture 2 2
Skin Infection 2 2
Swelling/ Edema 2 2
No Patient Involvement 2 2
Fungal Infection 2 2
Skin Discoloration 2 2
Injury 2 2
Skull Fracture 2 2
Contusion 1 1
Acoustic Shock 1 1
Fatigue 1 1
No Known Impact Or Consequence To Patient 1 1
Headache 1 1
Unspecified Infection 1 1
Limb Fracture 1 1
Multiple Fractures 1 1
Superficial (First Degree) Burn 1 1
Skin Inflammation/ Irritation 1 1
Contact Dermatitis 1 1
Unspecified Tissue Injury 1 1
Neck Pain 1 1
Impaired Healing 1 1
Hip Fracture 1 1
Pneumonia 1 1
Swelling 1 1
Discomfort 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Getinge (Suzhou) Co Ltd II Jun-04-2021
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